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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206644

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NDA 206644 describes PLERIXAFOR, which is a drug marketed by Amneal, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Meitheal, MSN, Teva Pharms Usa Inc, and Zydus Pharms, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the PLERIXAFOR profile page.

The generic ingredient in PLERIXAFOR is plerixafor. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the plerixafor profile page.

Summary for 206644

Tradename:	PLERIXAFOR
Applicant:	Gland
Ingredient:	plerixafor
Patents:	0

Pharmacology for NDA: 206644

Physiological Effect	Increased Hematopoietic Stem Cell Mobilization

Suppliers and Packaging for NDA: 206644

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	206644	ANDA	Sagent Pharmaceuticals	25021-416	25021-416-01	1 VIAL in 1 CARTON (25021-416-01) / 1.2 mL in 1 VIAL
PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	206644	ANDA	Gland Pharma Limited	68083-155	68083-155-01	1 VIAL in 1 CARTON (68083-155-01) / 1.2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	24MG/1.2ML (20MG/ML)
Approval Date:	May 3, 2024	TE:	AP	RLD:	No

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